Comparative Study Between Zirconia Crowns and Endocrowns in Pulpotomized Primary Molars

NCT04073901 | Completed

• 1 other identifier: 186
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: The new approach of pediatric esthetic dentistry intended to achieve a healthy beautiful smile rather than achieving only a beautiful smile. The objective of this study was to assess the clinical performance of ceramic Endocrowns and Zirconia crowns for the restoration of pulpotomized primary molars and parental satisfaction toward these crowns. Study design: Randomized clinical trial/split mouth design compared the clinical outcomes of two coronal restorations, on patients with bilateral carious second primary molars restoring one side with Endocrown (IPS e.max Press) and the other side with zirconia crown. Children attended Nahda University; Faculty of Dentistry clinics who need restorations screened for inclusion criteria till 20 patients are recruited (20 teeth for zirconia crown restorations and 20 for Endocrowns restorations). All children fulfilled the inclusion criteria were evaluated for factors including restoration integrity, marginal adaptation, marginal discoloration, oral health and overall clinical success at 3,6,12 months while parental satisfaction at 12 months follow up..

Conditions

Paediatric; Dentistry

Keywords

Aesthetic; Endo-crowns; primary; molars; pulpotomy; zirconium; crowns

Outcome Measures

Primary Outcomes (3)

• Restoration integrity

  Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)

  one year

• marginal adaptation

  Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)

  one year

• marginal discoloration

  Modified USPHS(United States Public Health Service (USPHS), alpha criteria rating system)

  one year

Secondary Outcomes (1)

• parent satisfaction

  immediate after intervention

Study Arms (2)

Endocrown

EXPERIMENTAL

Adhesive monoblock restoration for pulpotomized primary molars

Other: Endocrowns

Zirconia crowns

ACTIVE COMPARATOR

Prefabricated primary full coverage crown

Other: Endocrowns

Interventions

Endocrowns OTHER

Adhesive monoblock restoration for pulpotomized primary molars

Endocrown; Zirconia crowns

Eligibility Criteria

• Age: 4 Years - 7 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Free of systemic diseases.
• Age between 4 and 7 years.
• Takes no medication on regular basis.
• Has bilateral lower second primary molar with deep carious lesion, indicated for pulp therapy and crown restoration. (split mouth)
• Patient and parent compliance.

You may not qualify if:

• \. Non-restorable tooth. 2. Tooth near its exfoliation. 3. Tooth with extensive root resorption or periapical pathosis.

Sponsors & Collaborators

• Nahda University: lead

Study Sites (1)

Yassmine Mohamed Farouk El Makawi

Cairo, 11234, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: only satiation was blinded
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 29, 2019
• Study Start: February 2, 2018
• Primary Completion: June 3, 2018
• Study Completion: July 30, 2019
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)